Comparative Effects of Aspirin and SGLT2 Inhibitors on Liver Enzymes, Lipid Profile, and FibroScan Findings in Non-Alcoholic Fatty Liver Disease (AS-NAFLD)

Comparison Between the Effect of Aspirin and SGLT2 Inhibitor Intake in Non-Alcoholic Fatty Liver on Liver Enzymes, Lipid Profile, and the Results of FibroScan

Non-alcoholic fatty liver disease (NAFLD) is a prevalent hepatic manifestation of metabolic syndrome, encompassing a spectrum of liver disorders from steatosis to non-alcoholic steatohepatitis (NASH), with potential progression to advanced fibrosis, cirrhosis, and hepatocellular carcinoma. Given the global health burden of NAFLD, therapeutic interventions targeting its pathophysiological mechanisms are crucial.

Study Overview

• Status: Completed
• Conditions: Non Alcoholic Fatty Liver; Diabete Type 2
• Intervention / Treatment: Drug: Aspirin; Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy

Detailed Description

A randomized, controlled clinical trial will be conducted over 6 months with 80 participants diagnosed with NAFLD. Participants will be assigned to one of the groups including the Aspirin group (100 mg/day), and Empagliflozin 10 mg once daily. Primary outcomes include changes in liver enzymes, lipid profiles, and Fibroscan results, while secondary outcomes focus on clinical symptoms and metabolic indicators like body weight and waist circumference.

Statistical Analysis: Paired t-tests will compare pre- and post-treatment values within each group, while independent t-tests will assess differences between groups. A significance level of p<0.05 will be used.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt, 0000
      • Faculty of pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: if one or more the following are present:

• Diabetes mellitus, unless receiving only Dapagliflozin for treatment.
• Adult individuals (18-65 years) with a clinical diagnosis of NAFLD based on liver ultrasound
• No history of alcohol consumption or consumption within 3 months.
• Absence of other liver diseases.
• No significant renal or gastrointestinal issues that could interfere with treatment.

Exclusion Criteria:Patients were excluded from our study if one or more the -following are present:

• Pregnancy or breastfeeding.
• Active chronic viral hepatitis or autoimmune liver disease.
• History of gastrointestinal bleeding or other contraindications for Aspirin.
• Severe renal insufficiency.
• Alcohol intake

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aspirin group; Participants were received 100 mg of aspirin as oral daily doses for 6 months.	Drug: Aspirin; Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months.; Other Names: aspirin protect®
Experimental: Dapagliflozin group; Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months.	Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy; Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months.; Other Names: Diaflozimet ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lipid profile and Fibroscan results	Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months.; Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months.; Fibroscan results (liver stiffness measurement) at baseline and after 6 months.	6 months
lipid profile and Fibroscan evalution	Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months.; Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months.; Fibroscan results (liver stiffness measurement) at baseline and after 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
indicators of metabolic improvement	Improvement in clinical symptoms (fatigue, discomfort).; Impact on body weight and waist circumference (as indicators of metabolic improvement).	6 months

Collaborators and Investigators

• Sponsor: Galala University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): April 5, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Non-alcoholic fatty liver disease, Aspirin, Dapagliflozin, Liver enzymes, Lipid profile
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Liver Diseases; Fatty Liver; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Organic Chemicals; Pharmaceutical Preparations; Dosage Forms; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Salicylates; Hydroxybenzoates; Aspirin; Tablets; dapagliflozin
• Other Study ID Numbers: Galala U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No